Senior Executive-QA

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Division
Piramal Pharma Solutions
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
Senior Executive-QA
Job Description
IPQA activities like Sampling ,Line Clearance, Calibration, Shop floor Compliance etc.
Key Roles and responsibilities:
§ Ensure effective implementation of system and procedure as per cGMP, ISO 13485 in shop floor, warehouse and engineering along with documentation.
§ To ensure data integrity compliances at site and while performing activities.
§ To ensure the EHS (Environment, Health and Safety) related activities to be completed on time and to support EHS activities as per requirement. To report near miss and incidences as observed as per EHS requirement.
§ Monitoring of product quality, in-process control and manufacturing environment.
§ To perform AQL and in process test for manufacturing process as well as packing stage.
§ Approval of line clearance during product changes over/ Batch change over.
§ Sampling of Pooled samples, Micro sample, FG control samples, stability samples and other samples as per requirement along with related documentation.
§ To perform calibration of IPQA instrument.
§ Training of new employees, system practices and procedure to develop competency.
§ Review and approval of executed batch manufacturing, packaging documents & other quality documents.
§ Online stage wise BMR/BPR review.
§ Responsible for alarm/audit trail review and trending of alarm as and when required.
§ Handling of material on shop floor through approval for MRN, LRN, and MRQN.
§ Submission of In-process analysis report from QC to production after review.
§ Handling of non-conformance and Line failure activity along with related documentation.
§ Handling of Ensur, SAP & trackwise activity as per Quality Assurance procedure.
§ Handling of QAAS, CPV, and CLEEN software.